Metformin Versus Chlorhexidine Gel as Adjuncts to Scaling and Root Planing in Stage II Grade B Periodontitis

Chronic Periodontitis, Stage II, Grade B Periodontitis

Periodontitis, Stage II Grade B Periodontitis, Chronic Periodontitis, Scaling and Root Planing (SRP), Non-surgical Periodontal Therapy, Metformin Gel, Chlorhexidine Gel, Local Drug Delivery, Periodontal Regeneration, Inflammatory Markers (MMP-8)

This clinical trial is designed to evaluate two locally delivered gels, metformin and chlorhexidine, as adjunctive therapies to scaling and root planing (SRP) in patients with Stage II, Grade B periodontitis. Periodontitis is a chronic inflammatory condition that damages the supporting tissues of the teeth. Although SRP is the standard non-surgical treatment, it may not fully eliminate harmful bacteria or prevent disease recurrence. Chlorhexidine is a widely used antimicrobial gel, while metformin, a medication commonly prescribed for diabetes, has shown anti-inflammatory and bone-supportive effects when used locally in the gums. This study will directly compare the effectiveness of 1% metformin gel and 0.2% chlorhexidine gel, both applied subgingivally after SRP, against SRP alone. Sixty adult participants diagnosed with Stage II, Grade B periodontitis will be randomly assigned into three groups: SRP only (control), SRP plus metformin gel, and SRP plus chlorhexidine gel. Clinical outcomes (plaque index, gingival index, probing pocket depth, and clinical attachment level), inflammatory markers (MMP-8 in gingival crevicular fluid), and radiographic bone density will be measured at baseline, 1 month, 3 months, and 6 months. The goal is to determine whether metformin gel or chlorhexidine gel provides superior improvements in periodontal healing when compared with SRP alone. Findings from this trial may guide evidence-based decisions on optimizing non-surgical periodontal therapy.

This is a randomized, controlled, single-blind clinical trial conducted at the Department of Oral Medicine, Periodontology, Oral Diagnosis, and Oral Radiology, Faculty of Dentistry, Kafrelsheikh University, Egypt. Sixty participants aged 18-60 years with Stage II, Grade B periodontitis will be enrolled. Participants will be randomly allocated (1:1:1) into three groups: Group A (Control): SRP only Group B (Test 1): SRP + 1% Metformin Gel Group C (Test 2): SRP + 0.2% Chlorhexidine Gel Subgingival gels will be applied after SRP using sterile syringes, followed by periodontal pack placement for one week. All patients will receive standardized oral hygiene instructions. Outcome Measures: Primary Outcomes: Clinical attachment level (CAL) changes, reduction in inflammatory markers (MMP-8), and radiographic bone density gain. Secondary Outcomes: Probing pocket depth (PPD), plaque index (PI), and gingival index (GI). Follow-up assessments will be performed at 1, 3, and 6 months. Data will be statistically analyzed using ANOVA and paired t-tests, with significance at p \< 0.05. The trial has been reviewed and approved by the Scientific Research Ethics Committee, Faculty of Dentistry, Kafrelsheikh University (Approval No. KFSIRB200-564, dated 24 February 2025).

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